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Adding bulking agent to rhBMP-2 could produce a substitute for iliac crest graft

Nearly 82% of patients who received the combination achieved fusion at 6 months.

Issue: December 2007

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AUSTIN, Texas — Level 1 data suggests that combining an osteoconductive bulking agent with recombinant human bone morphogenetic protein-2 and an absorbable collagen sponge may be an effective replacement for iliac crest bone graft in lumbar fusion.

In a prospective, randomized trial, investigators compared patients who had single-level instrumented posterolateral fusion with either iliac crest bone graft or recombinant human bone morphogenetic protein-2 and an absorbable collagen sponge [rhBMP-2/ACS, or Infuse Bone Graft, Sofamor Danek], combined with an osteoconductive bulking agent [MasterGraft Granules, Medtronic].

The investigators discovered significant improvements over baseline results at 12 months for both groups regarding Oswestry Disability Index, Physical Component Summary Scale of the Short Form-36, back pain and leg pain scores, but no significant differences between the groups using these measures.

Better fusion rates

However, using the investigational device exemption (IDE) criteria for fusion revealed that more Infuse patients fused than the control group at 6 and 12 months follow-up. Thin-cut CTs also showed that more patients in the Infuse group had bridging bone at 6 and 12 months.

“Infuse bone graft combined with MasterGraft — or so-called ‘bulking of bone’ — was an effective replacement for iliac crest bone graft,” Hyun W. Bae, MD, said during his presentation at the North American Spine Society 22nd Annual Meeting.

The study included primary fusion patients who failed 6 months of conservative treatment and had less than Grade I degenerative disc disease.

In the investigational group of 25 patients, surgeons used 12 mg of rhBMP and enclosed 10 cc of MasterGraft granules in the collagen sponge. “It was 5 cc of MasterGraft and 6 mg of BMP per side for one level,” Bae said.

In the control group of 21 patients, surgeons used an average of 42.4 cc of iliac crest bone graft.

No difference in operative time

They saw no significant differences between the groups regarding patient demographics, operative time or length-of-hospital stay. They found more estimated blood loss in the iliac crest bone graft group, which Bae said was likely due to graft harvesting.

“Mastergraft, which is a mixture of HA (hydroxyapatite) and TCP (beta-tricalcium phosphate), does seem to have an optimum resorption characteristic for the use of BMP,” Bae said. “If you use a bulking agent such as DBM allograft, you may not get this response due to the resorption of the bulking agents themselves.”

For more information:

• Hyun W. Bae, MD, can be reached at The Spine Institute, 1301 20th St. #400 Santa Monica, CA 90404; 310-828-7757; e-mail: hbae@espineinstitute.com. He receives consultant fees, trips and travel support and research support for staff and materials from Sofamor Danek.

Reference:

• Bae HY, Stambough J, Glassman SD, et al. Level 1 data comparing rhBMP-2/ACS combined with an osteoconductive bulking agent with iliac crest bone graft in posterolateral lumbar fusion. Presented at the North American Spine Society 22nd Annual Meeting. Oct. 23-27, 2007. Austin, Texas.